Zai Lab to Present at 44th Annual J.P. Morgan Healthcare Conference

On January 5, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that members of the Company’s senior management team will participate in the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13th, 2026, at 3:00 p.m. PST / 6:00 p.m. EST.

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A live webcast of the presentation will be available on the Investor Relations page of Zai Lab’s website at ir.zailaboratory.com/webcasts-presentations, and an archived replay will be available for up to 30 days following the completion of the event.

(Press release, Zai Laboratory, JAN 5, 2026, View Source [SID1234661734])

Natera Presents Updated Analyses From ALTAIR Clinical Trial at ASCO GI

On January 5, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that new data from the ALTAIR trial will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), taking place January 8-10, 2026.

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A new analysis will be presented from the randomized, double-blind, phase III ALTAIR clinical trial (NCT04457297). ALTAIR examined treatment on molecular recurrence (TOMR) with Trifluridine/Tipiracil (FTD/TPI) in Signatera-positive patients with stage I-IV colorectal cancer (CRC). This investigator-initiated analysis, based on a post-hoc blinded central radiographic review that resulted in the reclassification of a subset of cases, showed a statistically significant DFS benefit of FTD/TPI vs. placebo in all patients (median DFS 9.23 vs 5.55 months; HR: 0.75, 95% CI: 0.55-0.98; P=0.0406). Importantly, these findings represent a substantial update from the previously reported overall ALTAIR analysis, which showed a numerical DFS improvement that did not reach statistical significance in the full study population.

In addition to ALTAIR, Natera’s ASCO (Free ASCO Whitepaper) GI presentations include a large-scale study on Signatera velocity as a prognostic marker for relapse risk stratification. In the study, CRC patients whose Signatera levels doubled in one month or less experienced ~40% shorter recurrence free survival (RFS) vs patients with slower doubling time. The prognostic association between the rate of circulating tumor DNA (ctDNA) increase and recurrence risk remained significant for patients who received adjuvant chemotherapy, as well as those who did not. This data is specific to Natera’s quantification method, which uses mean tumor molecules (MTM) per mL of plasma.

"Natera’s unmatched scale of evidence across tumor types uniquely positions the company to define ctDNA dynamics and translate them into meaningful biological insight and clinical action," said Adham Jurdi, M.D., senior medical director of GI oncology at Natera. "We believe these capabilities, including TOMR approaches, can ultimately support more precise risk stratification and cancer management."

The full list of 14 presentations at ASCO (Free ASCO Whitepaper) GI includes:

January 8, 11:30 AM PT | Abstract # 440
Presenter: Sahar Forootan Sedigh
Tumor-informed ctDNA monitoring during surveillance for early detection of recurrence in patients with stage II/III esophageal cancer treated with chemoradiation

January 8, 11:30 AM PT | Abstract # 843
Presenter: Axel Grothey, M.D.
AI-assisted automated abstraction for enhanced patient insights in gastrointestinal cancers

January 8, 11:30 AM PT | Abstract # 814
Presenter: Gladys Magaly Rodriguez, M.D., MS
Characterization of DPYD variants across ancestries in a large real-world cohort of cancer patients

January 9, 11:30 AM PT | Abstract # 778
Presenter: Elishama Kanu, M.D., MA
Prognostic value of ctDNA monitoring in patients with resectable pancreatic ductal adenocarcinoma during surveillance

January 10, 7:00 AM PT | Abstract # 163
Presenter: George Q. Zhang, M.D., MPH
Physical activity and molecular residual disease (MRD) in stage III colon cancer: Findings from CALGB (Alliance)/SWOG 80702

January 10, 7:00 AM PT | Abstract # 216
Presenter: Saori Mishima, M.D., Ph.D.
Assessing adjuvant chemotherapy benefit in younger and older molecular residual disease-positive patients with stage II/III colorectal cancer

January 10, 7:00 AM PT | Abstract # 221
Presenter: Naoya Akazawa, M.D.
Prognostic value of presurgical circulating tumor DNA (ctDNA) levels and other clinical factors in colon cancer

January 10, 7:00 AM PT | Abstract # 220
Presenter: Koji Ando
Correlation between the timing of recurrence and circulating tumor DNA (ctDNA) doubling time in patients (pts) with resected colon cancer

January 10, 7:00 AM PT | Abstract # 153
Presenter: Kozo Kataoka, M.D., Ph.D.
Adjuvant mFOLFOXFIRI after curative-intent resection of oligometastatic colorectal cancer: Phase II FANTASTIC trial

January 10, 7:00 AM PT | Abstract # TPS268
Presenter: Anwaar Saeed, M.D.
NSABP FC-13 (EMPIRE): A phase II platform study of cemiplimab monotherapy or cemiplimab-based combinations in patients with colorectal cancer and minimal residual disease (MRD) after definitive therapy

January 10, 7:00 AM PT | Abstract # 138
Presenter: Jun Watanabe, M.D., Ph.D.
Post-hoc central radiological review of the ALTAIR study in patients with molecular residual disease (MRD) following curative resection of colorectal cancer (CRC)

January 10, 7:00 AM PT | Abstract # TPS245
Presenter: Sarah Sawyer, Ph.D.
Design of a hybrid site and decentralized clinical research study of an early detection blood test for colorectal cancer

January 10, 7:00 AM PT | Abstract # 217
Presenter: Yoshiaki Nakamura, M.D., Ph.D.
Quantification of circulating tumor DNA (ctDNA) using a methylation-based, tissue-free colorectal cancer (CRC) test for the detection of molecular residual disease (MRD)

January 10, 11:30 AM PT | Abstract # 12 (Oral Presentation)
Presenter: Hideaki Bando, M.D., Ph.D.
Impact of postoperative ctDNA dynamics on eligibility for the ALTAIR randomized trial in patients with colorectal cancer: Implications for clinical trial enrollment

(Press release, Natera, JAN 5, 2026, View Source [SID1234661733])

Kelun-Biotech Announces Breakthrough Therapy Designation Granted in China for Sacituzumab Tirumotecan (sac-TMT) in Combination with Immunotherapy Pembrolizumab for First-Line Treatment of PD-L1-Positive NSCLC

On January 5, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company," 6990.HK) reported that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱) in combination with MSD’s anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA[1]) was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have PD-L1 tumor proportion score (TPS)≥1% and are EGFR-negative and ALK-negative.

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BTD is granted for treatment regimens that provide effective treatment or prevention for conditions with no currently available therapy, or that demonstrate significant clinical advantages over currently available treatments. For drugs included in the breakthrough therapy process, if relevant conditions are met, applications for conditional approval and priority review and approval can be submitted when applying for marketing authorization.

Previously, the company announced that results from the Phase III clinical trial of OptiTROP-Lung05, evaluating sac-TMT in combination with pembrolizumab as first-line treatment for PD-L1-positive NSCLC, demonstrated a statistically significant and clinically meaningful improvement in its primary endpoint of progression-free survival (PFS). A positive trend was also observed in overall survival (OS). OptiTROP-Lung05 is the first Phase III study of an immunotherapy and ADC combination to meet its primary endpoint in the first-line treatment of NSCLC. Granting of BTD for the first-line treatment of PD-L1-positive NSCLC indication offers pathways to expedite the review and potential approval process of sac-TMT for this indication.

To date, sac-TMT has received five BTDs for:

locally advanced or metastatic triple-negative breast cancer (TNBC) in July 2022;
locally advanced or metastatic EGFR-mutant NSCLC after progression on EGFR-TKI therapy in January 2023;
locally advanced or metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) in patients who have previously received at least two lines of systemic chemotherapy in June 2023;
first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC in March 2024;
In combination with anti-PD-L1 monoclonal antibody tagitanlimab for the first-line treatment of locally advanced or metastatic non-squamous NSCLC without actionable genomic alterations in June 2025.
About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, three indications for sac-TMT have been approved and marketed in China for: EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; Unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. The first two indications listed above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinical benefits to a greater number of cancer patients.

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. In addition, the sNDA for sac-TMT for second-line and above treatment of HR+/HER2- BC was accepted by the Center for Drug Evaluation of the National Medical Products Administration, and was included in the priority review and approval process.

As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, JAN 5, 2026, View Source [SID1234661732])

IDEAYA Biosciences Announces Participation at the 44th Annual J.P. Morgan Healthcare Conference

On January 5, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation at the 44th Annual J.P. Morgan Healthcare Conference.

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44th Annual J.P. Morgan Healthcare Conference
Monday, January 12th, 2026, at 3:45 PM PT (6:45 PM ET)

Presentation by Yujiro S. Hata, Chief Executive Officer, IDEAYA Biosciences, followed by analyst-hosted Q&A with Anupam Rama, Managing Director, US SMID Biotechnology Equity Research, J.P. Morgan
A live audio webcast of the presentation and Q&A session will be available under the "Investors/Events" section of the IDEAYA website at View Source and/or through the conference host. A replay of the webcast will be accessible for 30 days following the live event.

(Press release, Ideaya Biosciences, JAN 5, 2026, View Source [SID1234661731])

Kelun-Biotech Receives Investigational New Drug Approval for ITGB6-Targeted ADC SKB105 from the NMPA

On January 5, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported that its Investigational New Drug (IND) application for SKB105 (also known as CR-003), an internally developed integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC), has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of advanced solid tumors.

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In December 2025, Kelun-Biotech and Crescent Biopharma, Inc. ("Crescent") entered into a strategic collaboration for SKB105/CR-003 and SKB118 (a PD-1 x VEGF bispecific antibody, also known as CR-001). Under the collaboration, Kelun-Biotech granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105/CR-003 in the United States, Europe and all other markets outside of Greater China. In addition, Crescent granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China. The IND application for SKB118/CR-001 has been cleared by the U.S. Food and Drug Administration (FDA) with a global Phase I/II clinical trial for the treatment of advanced solid tumors is set to commence shortly. Kelun-Biotech plans to submit an IND application for SKB118/CR-001 to the Center for Drug Evaluation of the National Medical Products Administration of China in the near future.

About SKB105 (also known as CR-003)

SKB105 is a differentiated ADC targeting ITGB6 with a topoisomerase I inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. SKB105 incorporates proprietary Kthiol irreversible conjugation technology, linking an anti-ITGB6 fully human Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) to a clinically validated cleavable linker. This design aims to enhance stability and tumor-specific payload delivery while reducing adverse effects. In preclinical models, SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile.

About SKB118(also known as CR-001)

SKB118/CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, SKB118/CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. SKB118/CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, particularly in conjunction with ADCs.

(Press release, Kelun, JAN 5, 2026, View Source [SID1234661730])